With more than two million page views and more than 4,500 items, this blog provides news and commentary on public policy, business and economic issues related to the $3 billion California stem cell agency, officially known as the California Institute for Regenerative Medicine(CIRM). David Jensen, a retired California newsman, has published this blog since January 2005. His email address is djensen@californiastemcellreport.com.

Tuesday, August 16, 2011

Here is the text of what the California stem cell agency said concerning the unusual procedures in the approval of the $25 million loan to Geron in May 2011. The statement came in response to emailed questions from the California Stem Cell Report. James Harrison of Remcho, Johansen & Purcell of San Leandro, Ca., outside counsel to the board, prepared the statement after consulting with the chairman, vice chairmen and senior management of the agency.

Here are the questions posed by the California Stem Cell Report..

"Why wasn't the grant scored?
"Were the other applicants encouraged by CIRM in any manner to drop their applications? Were the other applicants given any sort of assurances -- including a wink or a nod -- indicating that they would be approved or have a better chance later?
"Why wasn't the grant reviewers' summary posted on the CIRM web site? Was a grant review summary ever prepared?
"Does CIRM expect that its conduct in this case will inspire confidence on the part of other applicants that they will receive fair treatment in the future? How does the unusual handling of this round square with CIRM's vows to adhere to the highest standards of openness and transparency?"

Harrison's response:

"Before I answer your questions, I wanted to provide you with some context. As you know, the Targeted Clinical Development Award program represented CIRM’s first effort to fund clinical research, a highly specialized area of medical research. As a result, CIRM had to develop new criteria and processes for the review of applications. In addition, the agency hired Dr. Ellen Feigal, who has tremendous clinical experience, as Vice President for Research and Development to oversee CIRM’s clinical program. Indeed, Ellen participated in the Grant Working Group’s Targeted Clinical Development review within days of being hired. We recognized when we issued the Targeted Clinical Development RFA that this was an iterative process and we intended to learn from this first effort in order to refine our procedures for future rounds of clinical awards. We have already begun to work on these refinements, including a procedure to obtain supplemental information which will be presented to the Board in August.

"It is also important to bear in mind that one of CIRM’s major goals is to collaborate with the biotechnology and pharmaceutical sectors to bring therapies from the bench to the bedside, and CIRM’s clinical trial program represents one of our most important opportunities to engage with companies. In order to work with companies, we need to be able to assure them of CIRM’s capacity to protect their proprietary information and their ability to obtain financing. This is particularly true for companies involved in clinical research:. At this stage of commercial product development, many things are proprietary (e.g., FDA communications, data, clinical plans, etc.); therefore, CIRM has a significant challenge and responsibility to protect the confidentiality of the companies’ submissions as any violation could have adverse consequences for the companies, including a material disclosure, particularly for those companies that are publicly traded. Thus, we were mindful of the importance of protecting the confidentiality of the applicants for Targeted Clinical Development Awards.

"With that context, here are our answers to your specific questions:

"Why wasn't the grant scored? The Grants Working Group did score the application, but given the fact that the application was reviewed pursuant to new criteria and was the only application presented to the Board, we concluded that presenting the score without context would have been confusing. We therefore presented the GWG’s recommendation without the score.

"Were the other applicants encouraged by CIRM in any manner to drop their applications? Every applicant for CIRM funding has the right to withdraw its application for funding before the Board considers the application. In this case, three applicants, on their own volition, withdrew their applications before the Board meeting and therefore the applications were not presented to the Board.

"Were the other applicants given any sort of assurances -- including a wink or a nod -- indicating that they would be approved or have a better chance later? CIRM has made no assurances, either directly or indirectly, to any applicants, including the applicants for the Targeted Clinical Development Awards, regarding future funding. CIRM does try to assist applicants by providing feedback, where appropriate.

"Why wasn't the grant reviewers' summary posted on the CIRM web site? A public summary was prepared and posted on CIRM’s website; given the fact that much of the information relating to the review was proprietary, the summary was, by necessity, brief.

"Was a grant review summary ever prepared? Yes, see above.

"Does CIRM expect that its conduct in this case will inspire confidence on the part of other applicants that they will receive fair treatment in the future? Yes, we believe that the care CIRM took in protecting the confidential information of applicants serves applicants, grantees and the public. The protection of applicants’ confidential information is critical to CIRM’s success."

"How does the unusual handling of this round square with CIRM's vows to adhere to the highest standards of openness and transparency? CIRM’s mission is to fund research to find therapies and cures for chronic disease and injury – we believe that CIRM’s handling of the clinical trial awards serves this goal and is consistent with our commitment to transparency and to protecting applicants’ confidential information."

After receiving Harrison's comments, we asked the following questions.

"I cannot find a summary of the reviewers comments. The only thing that I turned up was this, which is not a summary of what the reviewers had to say as provided in other grants:
http://www.cirm.ca.gov/summary-application-ct1-05168

"Perhaps you can point me to something else.

"Given the great departure from normal grant review procedures, why was
there no attempt to explain that in public at the May meeting? But
perhaps I missed it in the transcript. Thanks."

Harrison replied,

"You identified the correct summary. As I mentioned in my earlier email, because of the proprietary nature of the information, the review summary was, by necessity brief. This was CIRM's first clinical trial review and we expect to strengthen and refine the procedures for the next round, including explaining to the public how and why clinical review summaries differ from other CIRM grant review summaries."

About Me

The California Stem Cell Report is the only nongovernmental website devoted solely to the $3 billion California stem cell agency. The report is published by David Jensen, who worked for 22 years for The Sacramento Bee in a variety of editing positions, including executive business editor and special projects editor. He was the primary editor on the 1992 Pulitzer Prize-winning series, "The Monkey Wars" by Deborah Blum, which dealt with opposition to research on primates. Jensen served as a press aide in the 1974 campaign and first administration of Gov. Jerry Brown. (Time served: two years and one week.) He writes from his sailboat on the west coast of Mexico with occasional visits to land. Jensen began writing about the stem cell agency in 2005, noting that it is an unprecedented effort that uniquely combines big science, big business, big academia, big politics, religion, ethics and morality as well as life and death. The California Stem Cell Report has been identified as one of the best stem cell sites on the Internet. Its readership includes the media (both mainstream and science), a wide range of academic/research institutions globally, the NIH and California policy makers.